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510(k) Data Aggregation
(336 days)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.
50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.
The document describes the acceptance criteria and performance of the Disposable Medical Mask (Model: RYSM001) manufactured by Yangzhou Runyi Arts & Crafts CO., LTD. It is a 510(k) summary demonstrating substantial equivalence to a predicate device (Single-use Medical Face Mask, K203591 from Conod Medical Co., Limited).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Level 2: 29 out of 32 passed at 120 mmHg (AQL 4%) | Pass (32 out of 32 passed at 120 mmHg, Level 2 Fluid Resistance) in non-clinical testing, and stated as "Pass" in the summary table. |
| Particulate Filtration Efficiency at 0.1 micron (ASTM F2299) | Level 2: ≥ 98% (AQL 4%) | Pass (≥99% as per comparison table, and stated as "Pass" in the summary table). Also, average 99.80% reported for the predicate device, with similarity claimed for the proposed device. |
| Bacterial Filtration Efficiency (ASTM F2101-19) | Level 2: ≥ 98% (AQL 4%) | Pass (≥99% as per comparison table, and stated as "Pass" in the summary table). Also, average 99.77% reported for the predicate device, with similarity claimed for the proposed device. |
| Differential Pressure (Delta P) (MIL-M-36954C) | Level 2: |
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